MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT 2 CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number AWG2-25-450-A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved and the photo provided from the customer confirmed the report.There is wire guide coating damage near the distal end.The photo shows damaged coating near the distal tip of the device, but the core wire can not be seen.A visual inspection of the wire guide was performed and the coil spring is exposed approximately 1.1cm starting from the distal tip.No section of the device appears to be missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A lab meeting with production supervision was held to evaluate the state of the returned device and condition of the distal tip.A manufacturing defect associated with the manufacturing process at the distal end of the wire guide was unable to be confirmed.Devices released for distribution go through multiple inspections to detect such defects.Inspections include visually verifying distal end of wire guide is smooth and free of sharp edges or points and inspecting product for kinks.Therefore, it is unknown how or at what point the coating at the distal tip became damaged.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all acrobat® 2 calibrated tip wire guides are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

Prior to an endoscopic procedure, the physician prepared a cook acrobat® 2 calibrated tip wire guide.When the physician was injecting saline into the wire guide holder, it was noted foreign matter was at the tip of the wire guide.Another wire guide was used to complete the procedure.This event was not reportable at this time.The device was evaluated on 19-oct-2020 and it was noted there was coating damage at the distal end exposing the core wire.

• Brand Name: ACROBAT 2 CALIBRATED TIP WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 10835799
• MDR Text Key: 227614602
• Report Number: 1037905-2020-00482
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002476117
• UDI-Public: (01)10827002476117(17)220927(10)W4266633
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2022
• Device Catalogue Number: AWG2-25-450-A
• Device Lot Number: W4266633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1